News & Analysis as of

Mobile Devices Food and Drug Administration (FDA)

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

BakerHostetler

AD-ttorneys@law - March 2023

BakerHostetler on

Consumer Sues Pyrex Maker for False Made-in-the-States Claims - New class actions pick up where the FTC left off - Tempest in a Ten-Piece Glass Meal Prep Set - We love false made-in-the-USA claim narratives. They...more

Nossaman LLP

FDA Policy for Mobile Medical Applications

Nossaman LLP on

The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more

Polsinelli

Mobile Health Devices and Cybersecurity: Federal Guidance for Management of Threats in Medical Devices

Polsinelli on

New Technology = New Threats - With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating. The...more

Knobbe Martens

AliveCor, Inc., Maker of Smart Phone-Based ECG Device, Receives FDA Clearance for Two New Algorithms that Provide Users Immediate...

Knobbe Martens on

San Francisco-based AliveCor,Inc. recently announced that the U.S. Food and Drug Administration (FDA) granted the company clearance for two new algorithms for its Smart Phone-based ECG device, the AliveCor Heart Monitor and...more

Pillsbury - Internet & Social Media Law Blog

FDA Draft Guidance Would Ease Regulatory Burdens for Certain mHealth Applications

On August 1, 2014, the Food and Drug Administration (FDA) released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices--including certain mobile applications that can convert a cell...more

Morgan Lewis

FDA to Cease Active Regulation of MDDS and Other Health IT Devices

Morgan Lewis on

The draft guidance also enables some health IT manufacturers to avoid the device tax. The Food and Drug Administration (FDA) took an unusual step on June 20 by issuing new draft guidance that states its intent to not...more

Troutman Pepper

Privacy And Data Security For Life Sciences And Health Care Companies

Troutman Pepper on

Pepper Hamilton Health Care-Life Sciences Webinar - The explosion of mobile technology and Web applications linking patients with doctors, pharmacies and medical devices is undergoing scrutiny by the FDA, FTC, HHS and...more

Morgan Lewis

FDA Issues Long-Awaited Final Guidance on Mobile Medical Applications

Morgan Lewis on

Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients. On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more

Sheppard Mullin Richter & Hampton LLP

The FDA Releases Long-Awaited Final Guidance on Mobile Medical Applications

On September 23, 2013, the U.S. Food and Drug Administration (the “FDA” or the “Agency”) issued long-awaited final guidance for developers of mobile medical or health applications (or “mobile medical apps”) used on...more

Mintz - Health Care Viewpoints

FDA Issues Final Mobile Medical App Guidance

The U.S. Food and Drug Administration (FDA) has issued long-awaited final guidance for developers of mobile medical apps. The final guidance comes more than two years after the FDA published its draft guidance in July 2011. ...more

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